{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ECZEMA OATMEAL OATMEAL OATMEAL Water medium-chain triglycerides cetyl alcohol stearic acid cetearyl olivate sorbitan olivate canola oil allantoin calendula officinalis flower VIOLA TRICOLOR WHOLE yucca schidigera root aloe vera leaf rosemary lavender oil clary sage oil fytic acid caprylhydroxamic acid GLYCERYL MONOCAPRYLATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016."
      ],
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects & helps relieve minor skin irritation and itching due to: Rashes Eczema Poison ivy, oak, or sumac Insect bites"
      ],
      "warnings": [
        "Warnings For external use only When using this product Do not get into eyes. Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact Poison Control within the U.S. (1-800-222-1222)"
      ],
      "when_using": [
        "When using this product Do not get into eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact Poison Control within the U.S. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions Apply liberally onto desired area Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 133 mL Container Label CALIF♥RNIA BABY ® TRUSTED SINCE 1995 therapeutic relief™ GLUTEN-FREE! ECZEMA CREAM SKIN PROTECTANT OATMEAL & CALENDULA HELPS HEAL & PROTECT DELICATE SKIN FOR BABIES, KIDS & SENSITIVE ADULTS ALLERGY TESTED 133 mL/4.5 fl. oz. PRINCIPAL DISPLAY PANEL - 133 mL Container Label"
      ],
      "set_id": "926706b5-0a08-4604-b5ad-3b3ddfd7f02d",
      "id": "5fe6372b-07b4-40f8-9efe-2892256f2454",
      "effective_time": "20241105",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ECZEMA"
        ],
        "generic_name": [
          "OATMEAL"
        ],
        "manufacturer_name": [
          "ORGANIC & SUSTAINABLE BEAUTY"
        ],
        "product_ndc": [
          "52915-120"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "5fe6372b-07b4-40f8-9efe-2892256f2454"
        ],
        "spl_set_id": [
          "926706b5-0a08-4604-b5ad-3b3ddfd7f02d"
        ],
        "package_ndc": [
          "52915-120-45",
          "52915-120-05",
          "52915-120-02",
          "52915-120-19"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      }
    }
  ]
}